Zoekresultaten - 7 results
Belgian recommendations for analytical verification and validation of immunohistochemical tests in laboratories of anatomic pathology
a quality management system in anatomic pathology laboratories has been reviewed to meet this demand and additionally to prepare the laboratories for the EU — IVD revised regulations (IVDR). This paper ...
The GEONs API-fingerprint program: Tackling falsifications of APIs
product and therefore constitutes a direct threat to the health of patients (Position paper for OMCL s on API surveillance, EDQM). The conventional analytical approach often fails to detect falsification ...
CBD oils on the Belgian market: A validated MRM GC-MS/MS method for routine quality control using QuEChERS sample clean up
instruments and reduce the lifetime of the chromatographic columns. This paper proposes a procedure combining a sample cleanup by QuEChERS, removing the oily matrix, followed by a validated MRM GC- MS / MS ...
Characterization of suspected dermal fillers containing hyaluronic acid
can be used as a dermal filler. The latter frequently contains cross-linked HA. Today's methods to quantify the amount of cross-linked HA are not very specific. In this paper the development and ...
General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination.
introductory paper gathers general considerations on the biosafety of virus-derived vectors that are used in human gene therapy and/or vaccination. The importance to assess the potential risks for human health ...
Concept paper: rationale for deletion of the O-acetyl test on meningoccocal vaccines guidelines
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; Christina von Hunolstein Source: (2020) Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laborator ...
Development and validation of a targeted LC-MS/MS quantitation method to monitor cell culture expression of tetanus neurotoxin during vaccine production
testing, in-process monitoring of TeNT production could benefit from animal and antibody-free analytical tools. In this paper, we describe the development and validation of a new and reliable antibody free ...